Kornimate/medical-research-clean huggingface dataset:
stem cell therapy in duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of this study was to study the effect of stem cell therapy in patients with duchenne muscular dystrophy.


Eligibility criteria:
inclusion criteria: * age group of 3-25 years * duchenne muscular dystrophy diagnosed on the basis of clinical presentation exclusion criteria: * presence of respiratory distress * presence of acute infections such as human immunodeficient virus/hepatitis b virus/hepatitis c virus * malignancies * acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction \< 30% * pregnancy or breastfeeding

Keywords: duchenne muscular dystrophy autologous bone marrow mononuclear cell therapy stem cells
respiratory microbiome and copd exacerbations (resmecopd)

Conditions: Pulmonary Disease, Chronic Obstructive; Exacerbation COPD

Summary: the global objective of this coordinated project is to test the following hypotheses: 1) the lung microbiome in chronic obstructive pulmonary disease (copd) is different in patients suffering from frequent exacerbations (fe) compared those who do not (ne ); 2) the microbial profile of patients with fe is associated with a different local and systemic inflammatory pattern; and 3) the inflammatory and immune characteristics of copd are modulated by the intestinal microbiome. the project is based on bronchoalveolar lavage (bal) for sampling lung microbiome, and includes analysis of regional variability (intrapulmonary) and temporal variability. the project will also assess the correlation between bal samples obtained from the proximal airway (oral cavity, oropharynx and sputum), and the representation of lung microbiome in them. a cohort of copd patients (n = 50 fe; n = 50 ne) and healthy subjects (n= 30), matched by age, sex and tobacco consumption. respiratory secretion samples will be collected in clinical stability samples, with resampling in a quarter of the participants at 6-9 months. coordinator project: bacterial and fungal microbiota will be determined by 16s rrna and its amplification and sequencing. virome and functional metagenomics will be analyzed in a quarter of the participants. subprojects: regional variability in the lung, local and systemic inflammatory response, and the relationship between the intestinal microbiome and inflammatory and clinical characteristics of the disease will be determined. the integration of the results will be performed using network medicine methodologies. the results of this project will help to understand the pathogenesis of copd and its exacerbations with the final aim to identify new therapeutic targets.


Eligibility criteria:
inclusion criteria: * spirometry: fev1/fvc \< 70%; fev1 between 50 and 80% predicted (gold ii/iii) * clinical stability (no therapeutic change and/or use of antibiotics) during 8 weeks. - the treatment received will be registered for post-hoc studies stratified by this condition. exclusion criteria: * drug addiction, alcohol abuse, * use of long-term oral or nebulised antibiotic therapy. * history of allergies, asthma or other chronic respiratory disease, sanitary worker, working exposure to dust or fumes. * other diseases: severe cardiovascular, neurological, psychiatric, renal, hepatic or gastrointestinal , that might interfere with the daily life activities.

Keywords: copd microbiome exacerbation
patients empowered with digital scripts: scalamed

Conditions: Technology

Summary: a prospective qualitative and quantitative controlled study, exploring the impact of patient centred digital prescriptions on health, in patients with chronic health conditions.

scalamed is an innovative new consumer centred solution for securing prescriptions through a blockchain solution - a cryptographic distributed database, that can give consumer access to their prescriptions at all times. it aims to solve interoperability challenges that exist in healthcare, by creating a ledger of prescriptions, and giving consumers access to this information to own and share as they need. the solution will be accessed through an application available on a smart phone, will be fully compliant with security and privacy laws, and will be made available to consumers, clinicians, and pharmacies enrolled in this study free of charge. the system also allows patients to monitor the usage of their prescriptions - eg when they need a new one, and allows them to choose how and where they want to use their prescriptions like with paper. this study will explore whether empowering consumers with their digital prescriptions in a digital format through a blockchain based methodology of storing and accessing their data, will improve the flow of clinically important information, improve the frequency of data sharing, improve the self-management of the patient, improve adherence to treatments, reduce interactions and adverse events associated with medications, reduce the burden on clinical practice, improve efficiency, reduce the amount of paper, increase consumer engagement and improve patient satisfaction.

Eligibility criteria:
inclusion criteria: * ages 18-85 * cognitively able to understand instructions and care for themselves * lives in the community (not institutionalised) * owner of a smartphone and able to use apps * on 3 or more chronic prescription medications * informed consent as documented by signature (appendix informed consent form) * has had experience with prescriptions in australia for at least 1 year * for the clinicians - any clinician who is using the scalamed prescription system in the holdsworth house * for pharmacists - who are utilising the scalamed system in one of the four clinics exclusion criteria: * known or suspected non-compliance, drug or alcohol abuse * inability to follow the procedures of the study due to language problems, psychological disorders, dementia of the participant * previous enrolment into the current study

Keywords: digital prescription application
examination of a new irrigation system for transanal irrigation in children with fecal incontinence

Conditions: Fecal Incontinence; Constipation - Functional

Summary: the aim of this study is to investigate if a new irrigation system for transanal irrigation (tai) is effective and more tolerable than the currently used system at the pediatric ward at aarhus university hospital.

this is a randomized, controlled study. this study will be performed at aarhus university hospital (denmark) and aalborg university hospital (denmark) following the same protocol. according to the initial randomization, children will be allocated to treatment with the new system (group a) or with the currently used system (group b). after a period of 6 weeks the child will crossover to use the contrary system. the hypothesis is that a tai system specifically developed for children will enhance the child's toleration of irrigation due to fewer reports on pain at insertion which will lead to better compliance. this outcome will induce a comparable or better effect on their fecal incontinence and reduce the needed follow-up period due to fewer incontinence relapse.

Eligibility criteria:
inclusion criteria: * fecal incontinence on neurogenic or non-neurogenic basis, where transanal irrigation is indicated. exclusion criteria: * morbus hirschsprungs disease. * anorectal malformations. * use of medication that are known to cause constipation (e.g. anticholinergics)

Keywords: transanal irrigation
detection of group a β-hemolytic streptococci in oral samples

Conditions: Group A β-Hemolytic Streptococci

Summary: this prospective, sample collection study will assess different oral and/or nasal sample types collected from patients suspected of suffering from gabhs pharyngitis to conduct research and development on innovative gabhs detection methods specific for each sample type.

study candidates are patients age 3 and older with complaints of sore throat and are suspected of suffering from gabhs pharyngitis. patients who consent and are found eligible will be enrolled in the study. subjects will be tested according to the conventional standard of care in addition to providing extra specimen samples for the study. after each patient has been tested according to conventional soc and has enrolled in the study, up to ten oral and/or nasal specimen samples will be collected . study participation is complete once all specimen samples are collected. most or all collected samples will be qualitatively tested and may also be quantitatively and/or semi-quantitatively tested for the presence of gabhs. some collected samples may additionally or alternatively be tested for other respiratory infections as well. (such as sars-cov-2, influenza, etc.)

Eligibility criteria:
inclusion criteria: 1. patient, either male or female, is age 3 years or older; 2. patient is suspected of suffering from gabhs pharyngitis, and is prescribed a throat culture by conventional soc; 3. patient or legal guardian is able to communicate with study personnel; 4. patient or legal guardian is able to understand oral and written information regarding the nature of the study and is willing to provide written informed consent. exclusion criteria: 1. patients presently on antibiotics prescribed by a physician for treatment or prevention of gas infection or has taken antibiotics within the past 3 days ( unless patient only first started taking antibiotics within the past 24 hour) 2. pregnancy 3. patients who took mouth rinse or taking oral treatment for mouth sores within 3 hours of study
high-dose steroid for knee arthroplasty patients expected to have postoperative pain

Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Knee Osteoarthritis; Perioperative/Postoperative Complications; Surgery; Opioid Use; Catastrophizing Pain; Chronic Pain

Summary: the purpose of the study is to test a higher dose of steroids(dexamethasone) given just prior to surgery in the setting of fast-track knee surgery with arthroplasty in a group of expected high pain responders and the effect on postoperative pain and postoperative inflammation.

this study compares a new high-dose dosage of steroids in the treatment of postoperative pain after knee arthroplasty in a fast-track setting in a group of expected high pain responders. the investigators compare the already used dose(medium dose) with a new high dose(hd) steroid given as an intravenous bolus after the spinal anaesthesia has been given, but before the surgery starts. the hypothesis is that by attenuating the inflammatory response to the surgery itself by the steroid dexamethasone, the investigators expect a reduction in postoperative pain upon ambulation 24 hours after unilateral knee arthroplasty. patients referred to unilateral total kneearthroplasty because of knee-osteoarthritis at hvidovre hospital, capital region of denmark or vejle hospital, south region of denmark are screened and offered inclusion in the study. the two groups will be randomized and double blinded. one group will be treated, as the current guideline in the investigator's orthopedic fast-track arthroplasty center, with the medium dose of steroid (0,3 mg dexamethasone/kg bodyweight). the other group wil be treated with a high dose of steroid (1,0 mg dexamethasone/kg bodyweight). the patients will be monitored the first 7 days after surgery, during the admission to the hospital, and by a pain-diary in the patients own home. blood tests will be taken preoperatively and postoperatively to determine the effect of the highdose steroid on the inflammatory response.

Eligibility criteria:
inclusion criteria: * age between 40 and 90. * booked for unilateral knee-arthroplasty. * is able to take part in the investigation(selfreported pain and nausea/vomiting) * understands danish or english, or has a translator available. * signed written consent. * a daily use of 30 mg or more of morphine or morphine equivalents . * a pain catastrophizing scale(pcs) score of \>20. exclusion criteria: * insulin-dependent diabetes melitus. * ongoing treatment with systemic glucocorticoids or immunosuppressing treatment(apart from inhaled glucocorticoids). * pregnancy/breastfeeding * allergies for the investigational drug. * a history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.

Keywords: knee arthroplasty knee replacement perioperative medicine
feasibility study of blood glucose monitoring with the non-invasive medical device d-base

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study aims to evaluate the feasibility of monitoring the blood glucose values by measuring the glucose in the interstitial fluid of the skin on the wrist of subjects with diabetes mellitus type 1 and 2.

the investigation is designed as an open, monocentric, non-randomized, single-arm, explorative study in adult subjects with type 1 or 2 diabetes mellitus (any therapy form). the clinical investigation will be performed in an outpatient setting on up to two study days with up to 100 subjects. a nearly equal number of subjects with diabetes type 1 and 2 shall participate in the study.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 1 or type 2 diabetes * hba1c \<10% * an understanding of and willingness to follow the protocol * signed informed consent exclusion criteria: * severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment * hypoglycemia unawareness * have extensive skin changes/diseases at the proposed measurement site (wrist) that could interfere with the accuracy of glucose measurements. * female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy) * serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection * severe diabetes related complications (i.e. severe macro angiopathy, severe micro angiopathy, severe neuro-, retino- or nephropathy) when unstable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy * any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, tremor, language barriers, alcohol or drug misuse * not able to understand, write or read german * dependency from the sponsor or the clinical investigator
phase 3 clinical trial to evaluate of the efficacy and safety of dw9801 in patients with primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: a multi-center, randomized, placebo-controlled, double-blind, cross-over, phase 3 clinical trial to evaluate of the efficacy and safety of dw9801 in patients with primary dysmenorrhea


Eligibility criteria:
inclusion criteria: * female patients, age between 19 years to 44years * patients with menstrual pain over 4 out of 6 menstrual cycles before screening * patients with moderate or severe menstrual pain for recent 2 menstrual cycles * patients with regular menstrual cycles(28±7 days) for a year exclusion criteria: * patients diagnosed or suspected of secondary dysmenorrhea * previous adverse reaction or known allergy to nsaids * breast feeding woman * patients who are not willing to use proper contraception during clinical trial period
the role of the free/pedunculated flap in total laryngectomy after (chemo-)radiotherapy failure for laryngeal carcinoma: impact on the risk of pharyngocutaneous fistula (pcf)

Conditions: Larynx Carcinoma

Summary: multicenter, prospective, randomized study aimed at evaluating the difference in risk of pcf after salvage laryngectomy in two groups of patients: one cohort treated with total laryngectomy (lt) with primary suture, a second group treated with lt and reinforcement by flap positioning with onlay technique (pmm, alt)

patients, once eligibility has been verified, will then be randomized (1:1) to one of the following groups: gruop 1: stl primary suture. group 2: stl primary suture + onlay flap patients in both groups will then undergo surgery stl with primary suture; in those of the second group, in addition, the positioning of a free/pedunculated covering flap will also be carried out with the onlay technique. 4 months after surgery, questionnaires will be administered to the patient for the subjective evaluation of the quality of life in relation to vocal rehabilitation obtained through voice prosthesis or esophageal voice (secel questionnaire) and swallowing rehabilitation (soal questionnaire). demographic and preoperative data will be collected, data relating to pre-(chemo-)radiotherapy and pre-stl clinical staging, as well as the interval in days between the end of (chemo-)radiotherapy and surgery, perioperative data, type of eventual unilateral or bilateral laterocervical lymph node emptying, the type of pharyngotomy suture, the type of flap possibly used, the packaging of the tracheoesophageal fistula for positioning the voice prosthesis, the definitive histological examination. the patient must undergo a radiological examination for loco-regional and distant staging before the stl (ct or mri) and a biopsy demonstrating the recurrence/persistence of the disease.

Eligibility criteria:
inclusion criteria: * histological confirmation of recurrence/persistence of squamous cell carcinoma of the larynx previously subjected to exclusive radiotherapy or concomitant chemo-radiotherapy treatment: 1. pre (cht-)rt staging: ct1/t2/t3 n0/n+; 2. pre stl staging: rct1/ct2/ selected ct3 ct4a (extension to thyroid cartilage and/or prelaryngeal tissues) n0/n+ (clinically and radiologically). * indication for stl surgery (no pharyngeal mucosal resection); * functional total laryngectomies after radical (chemo-)radiotherapy treatment; * age \> 18 years; * signature of informed consent and ability to complete in-office questionnaires. exclusion criteria: * stl extended to the pharynx and/or total pharyngeal laryngectomies; * extension of the tumor to the pharyngeal mucosa and/or massive extra-laryngeal extension; * previous open organ preservation surgery (ophl).

Keywords: pharyngocutaneous fistula
lower protein intake and long-term risk of obesity and cardiovascular disease

Conditions: Infant Formula; Growth

Summary: the primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.

obesity and its cardiovascular consequences are the most important causes of morbidity and mortality worldwide. breastfed infants have been shown to have less cardiovascular risk factors in adulthood, which can be partially explained by their slower growth compared to formula fed infants. the primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and atherosclerotic cardiovascular disease (cvd), the critical windows for these programming effects, and the mechanisms of action.

Eligibility criteria:
inclusion criteria: * healthy term infant * infant is aged 14 weeks (+/- 1 week) * infant is exclusively formula feeding or predominantly breast-feeding at age 14 weeks exclusion criteria: * any adverse maternal, fetal or infant medical history that may have effects on growth and/or development * infant born with congenital disease or malformation affecting growth and/or development * food allergy to any trial products (e.g. milk, soy)

Keywords: protein requirements adiposity body composition cardiovascular health
behavioral intervention to maintain physical capacity and activity in patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to investigate to what extent patients with copd, who have participated in physical training for 12 weeks, can maintain their physical activity behaviour and physical capacity on a long-term basis if they get a behavioural medicine intervention.

chronic obstructive pulmonary disease (copd) is a progressive disease and the number of patients is increasing. persons with copd have a low physical capacity and a low physical activity level. the risk of premature morbidity and mortality is high especially in persons with a low level of physical capacity and activity. rehabilitation including physical training is recommended and results in decreased morbidity and mortality and increased physical capacity and quality of life. unfortunately improvements decrease if patients do not maintain their physical activity level. to change physical activity behaviour in is challenging. different methods as social cognitive theory, sct and the transtheoretical model, ttm have been suggested as theoretical framework. according to sct, to improve physical activity behaviour you should use goal-setting, outcome expectancy, self-efficacy, and self-monitoring. to use motivational interviewing (mi) improves the success of a behaviour change. patients will be randomized after the 12-week training period, tested, and thereafter both the intervention group and the control group will get information about the importance of physical activity and the recommendations. thereafter patients in the intervention group will receive weekly telephone calls for the first month, telephone calls every second week for the following two months and thereafter monthly telephone calls for the following three months. the telephone calls will be in accordance with mi and discuss goal-setting, out-come expectancy, and self-monitoring. patients will be tested after 6,12,and 24 months.

Eligibility criteria:
inclusion criteria: * patients with copd at uppsala and umeå university hospitals, who have participated in physical training at the hospital for 12 weeks. * diagnose of copd exclusion criteria: * understand the swedish language * be able to be physically active

Keywords: copd behavioral intervention physical capacity physical activity
coginitve and physical functions in geriatric i̇ndividuals

Conditions: Cognitive Change; Physical Performance; Frailty; Mobility

Summary: the aim of this study is to investigate the relationship between cognitive functions with physical performance, grip strength, walking speed, mobility, and frailty in geriatric individuals. decline in cognitive function and decline in physical performance are generally associated with advanced age. cognitive dysfunction is a natural consequence of ageing and is an important factor in maintaining quality of life and independence. investigating the relationship between cognition, physical performance, mobility, and frailty has become a challenging issue in recent years. however, there is a need to further clarify the direction of this cognitive-motor link.


Eligibility criteria:
inclusion criteria: * volunteer healthy geriatric individuals aged 65 years and over * able to walk independently exclusion criteria: * without neurological and rheumatological diseases, * without acute musculoskeletal problems in the lower extremities